ICH GCP E6(R3) Training – Online Certification Course for Clinical Research
Comprehensive Training for Clinical Research Professionals
Format: Online, available 24/7
Instructors: International GCP auditors
Certification: Transcelerate-accredited with CPD points
Master ICH GCP E6(R3) updates with a course designed to ensure an efficient transition from E6(R2)
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Our course provides a comprehensive roadmap for successful adoption of ICH GCP E6(R3), enabling organizations to minimize compliance risks, optimize operational efficiency, and align with updated regulatory expectations.
The transition to ICH GCP E6(R3) introduces critical regulatory changes that impact everyone in clinical trials:
The transition to ICH GCP E6(R3) introduces critical regulatory changes that impact everyone in clinical trials:
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Risk-proportionate approach is now central to all clinical research activities, including quality management - Increased regulatory focus on digital systems requires validated data management and security.
- Adaptive processes enable more flexible trial management
- Revised investigator and sponsor responsibilities emphasize enhanced oversight, data integrity, and delegation
Our Key Advantages for You:
- E-learning and Blended Learning Approach100% Online: Self-paced modules with cartoons, quizzes, test cases and access to the series of webinars and Q&A sessions is a complement.
- Enhanced EngagementShort comprehensive cartoons to explain complex topics.
- Practical scenarios to simulate real-life cases.
- Mobile-compatible: Learn anytime, anywhere
- Accreditation
- Registered by Transcelerate
- CPD points
- Expert-Designed & Certified
- TransCelerate approved certification.
- Can be used for the study start (Investigators meeting and etc)
- Can be customized for other professionals or parties to whom the investigator has delegated trial-related activities
- Gamification Features (leaderboards, badges, and rewards).
- Customizable for Companies
- Customizable course content to align with company-specific needs
- In-person training sessions led by certified experts
- Option to develop a bespoke training module on your corporate platform
Choose Your Plan
Course for INVESTIGATOR
From 15 employees → €80 per person
€90
For Clinical Investigators, Study Coordinators and other Investigator site staff.
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Course For MONITOR
From 3 employees → €100 per person
€120
For Clinical Research Associates and similar roles (e.g., Central Monitoring Associates).
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Course For EXPERT
From 3 employees → €250 per person
€300
Sponsor and Service Providers clinical staff other than Monitor (e.g., Project Managers / Clinical Trial Managers), QA staff, and other similar roles
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WHAT YOU’ll LEARN
Each module combines theory with practical application, ensuring you gain actionable insights
Content:
- Overview of GCP principles and evolution from E6(R2) to E6(R3).
- Emphasis on the importance of flexibility, quality by design, and risk-based and risk-proportionate approaches in clinical trials.
Content:
- Core principles for ethical and scientifically sound trials.
- Focus on participant safety, data reliability, and trial integrity.
- Outcome: Grasp the updated principles and their implications for trial design and execution.
Content:
- Roles and responsibilities of IRBs/IECs.
- Key updates in submission, review, and oversight processes.
Content:
- Investigator qualifications, IMP, informed consent, records and safety reporting.
- Updates in risk-based delegation, oversight and other items in E6(R3).
Content:
- Sponsor oversight, trial design, quality management, and safety assessment.
- Comparisons: Quality assurance, monitoring and other changes from E6(R2) to E6(R3).
Content:
- Data capture, audit trails, validation, and lifecycle management
- Enhanced focus on computerized systems in E6(R3) and their validation.
Essential Documents:
- Content: Document requirements before, during, and after trials.
- Investigator’s Brochure (IB)
- Protocol and Amendments
Content:
- Review all modules with a focus on practical application.
Features
Investigator Level
Monitor Level
Expert Level
- General sections (Glossary, Introduction)
- The 13 GCP Principles
- IRB/IEC (Ethics Committees)
- Investigator responsibilities
- Data Governance
- Essential Records (Appendix C)
- Annex 2
8. Sponsor responsibilities relevant to monitoring activities
9. Appendices A and B
10. In-depth review of all E6(R3) sections, including complex and advanced topics
10. In-depth review of all E6(R3) sections, including complex and advanced topics
Confirm your participation in our individual or corporate training and receive exclusive access to the E6(R2) vs. E6(R3) Key Differences Chart.
A structured, practical reference. This guide is available only to participants and designed for continued use as an essential tool during the transition process.
A structured, practical reference. This guide is available only to participants and designed for continued use as an essential tool during the transition process.
Get access to the ICH GCP E6(R3) course demo
Explore the content, format, and expert approach behind the program — so you can make an informed decision.
Use this opportunity to ask questions and evaluate how the course fits your professional goals.
Explore the content, format, and expert approach behind the program — so you can make an informed decision.
Use this opportunity to ask questions and evaluate how the course fits your professional goals.